MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 110 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	110-300
Medical Device Problem Codes	Material Rupture (1546); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924); Seroma (2069)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The reason for reoperation is rupture.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Patient reported right side "broken inside." patient stated its "leaking inside [their] body", "three fake veins coming from under the implants", "the implant is moving around everywhere".Patient reported feeling "dizzy and foggy", "area seems deflated and is tingly".Device remains implanted.
Additional Manufacturer Narrative
Additional data: b.5, g.1, h.6.
Event or Problem Description
Patient reported additional events of capsular contracture, baker grade unknown, and cysts.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, b6, g1, g2, h6 the event of "seroma-late" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.
Event or Problem Description
Healthcare professional later reported "baker 4 capsular contracture, breast asymmetry, breast ptosis, breast implant rupture, dense breast tissue, and peri implant fluid is identified".Healthcare professional additionally reported "multiple cysts", which are not device-related.

• Brand Name: STYLE 110 SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 8613499
• Report Number: 9617229-2019-03954
• Device Sequence Number: 14008362
• Product Code: FTR
• UDI-Device Identifier: 10888628002227
• UDI-Public: 10888628002227
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2019
• Device Model Number: 110-300
• Device Catalogue Number: 110-300
• Device Lot Number: 2658428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 02/28/2020; 04/27/2022; 12/27/2022
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 03/25/2020; 05/23/2022; 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female